Hybrid ESD for Colorectal Lesions

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Florida, Gainesville, FL
Colorectal Lesions
Non-hybrid ESD - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This proposed trial will randomize 60 patients with a ≥20 mm large colorectal polyp to either undergo hybrid or non-hybrid ESD. For the primary comparison (hybrid vs non-hybrid ESD), the primary outcome will be procedure time. The study will further examine the safety and efficacy of hybrid ESD compared to non-hybrid ESD and investigate factors that may be associated with resection outcomes.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Colorectal Lesions

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: 6 months

1 day
Complete (R0) resection rate
Completeness of resection
ESD technical difficulty
En-Bloc resection rate
• The primary endpoint is to compare procedural time between hybrid vs non-hybrid ESD.
6 months
Incidence of overall severe adverse events
Polyp recurrence
Proportion of unremovable polyps

Trial Safety

Safety Progress

1 of 3

Other trials for Colorectal Lesions

Trial Design

2 Treatment Groups

Hybrid ESD
1 of 2
Non-Hybrid ESD
1 of 2
Active Control

60 Total Participants · 2 Treatment Groups

Primary Treatment: Hybrid ESD · No Placebo Group · N/A

Hybrid ESD
Procedure
ActiveComparator Group · 1 Intervention: Hybrid ESD · Intervention Types: Procedure
Non-Hybrid ESD
Procedure
ActiveComparator Group · 1 Intervention: Non-hybrid ESD · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: University of Florida · Gainesville, FL
Photo of University of Florida 1Photo of University of Florida 2Photo of University of Florida 3
2007First Recorded Clinical Trial
1 TrialsResearching Colorectal Lesions
783 CompletedClinical Trials

Who is running the clinical trial?

AdventHealthLead Sponsor
96 Previous Clinical Trials
20,332 Total Patients Enrolled
Dennis Yang, MDPrincipal InvestigatorAdventHealth Orlando
2 Previous Clinical Trials
1,054 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Patient scheduled to undergo colonoscopy with endoscopic resection of colorectal polyps.
You have a non-pedunculated polyp measuring ≥20 mm in lateral diameter by endoscopic estimation.
You are able to provide informed consent.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

References